K-number	K011143
Device name	TINA-QUANT D-DIMER TEST SYSTEM
Applicant	Roche Diagnostics Corp.
Product code	GHH
Device class	Class II
Decision date	May 29, 2001
Decision	Substantially Equivalent
Regulation	864.7320

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View the full FDA submission: accessdata.fda.gov

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TINA-QUANT D-DIMER TEST SYSTEM

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